1st Edition

Handbook of Medical Device Design




ISBN 9780367249403
Published May 7, 2019 by CRC Press
774 Pages

USD $235.00

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Book Description

First published in 2001: This handbook has been written to give those professionals working in the development and use of medical devices practical knowledge about biomedical technology, regulations, and their relationship to quality health care.

Table of Contents

Section 1: Standards and Regulations

1. FDA Regulations

Richard C. Fries

2. Preparing an FDA Submission

Richard C. Fries

3. European Standards and Regulations

Richard C. Fries

4. The Medical Device Directives

Richard C. Fries

5. The Basis of ISO 9001

Tina Juneau

6. Design of Medical Devices for the Canadian Market

Paul Fabry

7. Pacific Rim Standards and Regulations

Richard C. Fries

8. Overview of Software Standards

Nancy George

Section 2: Determining and Documenting Requirements

9. Defining the Device

Richard C. Fries

10. Documenting Product Requirements

Richard C. Fries

11. Medical Device Records

Richard C. Fries

Section 3: The Design Phase

12. Hazard and Risk Analysis

Markus Weber

13. Hardware Design

Richard C. Fries

14. Software Design

Sherman Eagles

15. Human Factors Engineering

Richard C. Fries

16. Biocompatibility

Richard C. Fries

17. Reliability Assurance

Richard C. Fries

18. Product User Guides

Margaret Rickard

19. Translation: "It’s a Small World After All"

Margaret Rickard

20. Liability

Richard C. Fries

21. Intellectual Property

Richard C. Fries

Section 4: Verification and Validation

22. Testing

Lisa Henn

23. Overview of Verification and Validation for Embedded Software in Medical Systems

Andre Bloesch

24. Software Verification and Validation

Sherman Eagles

25. Reliability Evaluation

Richard C. Fries

26. Analysis of Test Results

Richard C. Fries

Section 5: The Manufacturing/Field Phase

27. Quality System Regulation and Manufacturing

Richard C. Fries

28. Configuration Management

Richard C. Fries

29. The Quality System Audit

Tina Juneau

30. Analysis of Field Data

Richard C. Fries

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Editor(s)

Biography

Richard C. Fries is Manager of Reliability Engineering, Datex-Ohmeda, Inc., Madison, Wisconsin.

Reviews

"a worthwhile reference and source. . ..Biomedical and engineering libraries would benefit from this addition to their reference collections."
---E-Streams